MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-31 for YC-1800 manufactured by Nidek Co.,ltd.
[85626713]
Nidek inc. Considers pitting lens issue on yag laser a reportable event as the yc-1800 had malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur. Device evaluation in work process, a follow-up report will be submitted once the device evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[85626714]
On (b)(6) 2017, nidek inc. Customer service received a telephone call from a customer to report that their yc-1800 yag laser was not getting the same reaction and caused mild pitting during surgical procedure. Based on doctor's remarks, when the energy power was set at 2 mj, nothing happens to the lens/capsule during start of posterior. When firing, looks like nicks in the iol. Higher energy near the center of the iol was not used, because of some mild pitting. The procedure was eventually completed by turning the energy up to around 2. 4-2. 6 mj and aiming posteriorly. No report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2017-00022 |
| MDR Report Key | 6836698 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-31 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-08-18 |
| Date Mfgr Received | 2017-08-18 |
| Device Manufacturer Date | 2017-03-10 |
| Date Added to Maude | 2017-08-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. PREETI GANDHI BHATIA |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| Manufacturer Phone | 5103537718 |
| Manufacturer G1 | NIDEK CO., LTD. |
| Manufacturer Street | 34-14 HIROISHI |
| Manufacturer City | GAMAGORI, AICHI 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YC-1800 |
| Generic Name | YAG LASER |
| Product Code | LXS |
| Date Received | 2017-08-31 |
| Model Number | YC-1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO.,LTD |
| Manufacturer Address | 34-14 HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-31 |